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US Regulators Float Ideas for Boosting Medical Device Safety

Matthew Perrone, The Associated Press: April 17, 2018

U.S. health officials on Tuesday proposed steps to improve the government’s system for overseeing medical devices, which has been criticized for years for failing to catch problems with risky implants and medical instruments.

The plan from the Food and Drug Administration includes few immediate changes, but lists a number of ideas and proposals with the goal of improving safeguards on pacemakers, artificial joints, medical scanners and other devices.

Among other measures, the FDA will consider requiring more training for doctors who implant certain high-risk devices. But that step, like others floated by the agency, might require new guidelines or regulations. Other proposals may require additional money from Congress.

The FDA has repeatedly been forced to issue safety alerts about unexpected problems with devices that only appeared years after they were approved for use in patients. In the last decade, those have included hip replacements that failed prematurely, faulty wiring in implanted defibrillators, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.

“We want to have better tools for detecting issues that occur post-approval,” FDA Commissioner Scott Gottlieb said Tuesday. “But we also want to have better policies to quickly intervene and better inform patients and providers if we see adverse events happening.”

An agency critic said the report contains few concrete changes and “many sections that will please the device industry.”

“FDA’s safety strategies for medical devices are still years away from effective implementation,” said Diana Zuckerman, president of the National Center for Health Research, a consumer advocacy group. “Overall, the report indicates that the FDA’s approval standards for medical devices remain completely inadequate.” […]

Among other proposals laid out in the FDA’s “Medical Device Safety Action Plan,” the FDA will consider:

— How to quickly require additional safety requirements for certain devices, including training for doctors who work with the complex devices.

— Extra scrutiny of devices for women, following recent problems with vaginal mesh, the birth control implant Essure and surgical tools.

— New ways to encourage manufacturers to improve safety, including quicker approval for devices that appear safer than what’s available.

— Requiring cybersecurity features for electronic devices like implantable heart pacemakers and defibrillators.

The agency will also ask Congress for more money for a public-private system intended to monitor insurance claims, electronic health records and other data sources for early signs of device problems. The project is estimated to cost $250 million over five years to become operational; it is now slated to receive $30 million from device manufacturers.

Read the original article here.

After 17 Years with Breast Implants, Princeton Woman Leads Calls for More Education, Safety

Marie Saavedra, WFAA, April 16, 2018

A North Texas woman says her implants were making her sick. Now, she’s lending her voice to the call for more information to be shared between the FDA, doctors and patients.

Jamee Cook was 21, engaged to be married and a paramedic when she made a decision that would shape the rest of her life.

“I was really active. Healthy, Young, skinny,” she said. “I was always really really flat chested and wanted to be more proportionate.”

At age 21, Cook chose to get breast implants. At 40, it is her biggest regret.

“I mean, I made this decision and I own it,” she said. “And I do feel guilty about it because it took a lot of things away from me.”

She says that included her health. Three years after surgery she developed an auto immune disease.

“Then it went downhill, just chronic fatigue, swollen lymph nodes all the time, chronic sinus infections,” Cook said. “I couldn’t get out of bed, I was having migraines two or three times a week, and I had three young kids at home!”

She says doctors had no more answers, which left her feeling helpless. Cook turned to the internet and researched, and she came to realize her implants could be the source. She was certain when she removed them after 17 years.

“I still battle fatigue off and on, but the majority of my other symptoms went away immediately,” she said.

Cook then gained new purpose. She created the group Breast Implant Victim Advocacy, a community of thousands women who say implants made them ill. She lobbied for implant safety in Washington. All of it, driven by a simple goal.

“I think that a lot of women don’t get the information they need to make a fully informed decision,” she said.

Last year, the American Society for Aesthetic Plastic Surgery said surgeons performed 333,329 breast augmentations. We asked Dallas plastic surgeon Dr. Lawrence Weider about what warnings patients can currently expect to hear from their doctors.

“There’s a whole host of risks that we discuss,” said Dr. Weider. “We have a several page consent for that we go through with them.”

But Cook argues there’s more to be done. Right now, The FDA is researching the ties between a specific type of implant causing a rare lymphoma, and last month a woman suffering from that cancer sued an implant maker in California. […]

Read the original article here.

After 17 Years With Breast Implants, Princeton Woman Leads Calls for More Education, Safety

Marie Saavedra, WFAA-ABC: April 16, 2018


PRINCETON, Tx. — A North Texas woman says her implants were making her sick. Now, she’s lending her voice to the call for more information to be shared between the FDA, doctors and patients.

Jamee Cook was 21, engaged to be married and a paramedic when she made a decision that would shape the rest of her life.

“I was really active. Healthy, Young, skinny,” she said. “I was always really really flat chested and wanted to be more proportionate.”

At age 21, Cook chose to get breast implants. At 40, it is her biggest regret.

[…]

Read the original article here.

How to Appeal a Denial


If you disagree with your health insurer’s decision to not cover a service, you have the right to appeal this decision. Many appeals are approved. Some appeals are handled by your healthcare provider, but you can also appeal a decision yourself.

Follow these steps to file an appeal:

1. Gather all relevant information

The first step to appealing your insurer’s decision is to find out why your claim was denied. Get a copy of your denial letter and any document(s) submitted to your insurance as a part of the initial claim. This might include documents such as MRI findings, lab test results, operative reports, notes from your physician(s), letters of medical necessity, or medical bills related to the claim.

You should check your denial letter to find out when the deadline to file the appeal is. Your denial letter should explain when and how to file the appeal.

You will also want to get a copy of your insurance’s Evidence of Coverage document (sometimes called the benefit policy document). From this document you can determine what procedures your plan covers.

It can also be helpful to call the insurance company’s member services phone number. You can ask them for a detailed explanation of why the procedure was denied. If you can’t get a clear explanation that makes sense to you, you can ask to speak to a supervisor. Always ask the name of the people you speak with on the phone, write it down with the date you talk to them, and ask them to “put it in the record” that you’re working on disputing the claim.

2. File an appeal form or write an appeal letter

It is likely that your insurance company will have a standardized appeal form for you to fill out. If so, filling out their form will make the process move as quickly as possible. This form usually asks for most of the information you would include in an appeal letter.

If your insurance company does not have a standardized appeal form, you need to write an appeal letter asking your insurance company to reconsider their decision.   Even if your insurance company has a standardized appeal form, an appeal letter can sometimes add more persuasive evidence.

This is known as an internal appeal. If the internal appeal is denied, you can appeal for a review by an independent third party. This is called an external appeal. The decision made by the external board is usually final and can’t be appealed.

The appeal letter should include the following:

  • Your identification: your name, claim number, policy number, member ID number and any other information that will help identify you.
  • Reason for denial: quote the exact reason for denial that they explained in the denial letter.
  • Reason why you disagree with the denial: explain why you think the procedure should be covered. To make your case stronger, you can insert relevant language from your insurance policy document that indicates the procedure should be covered. You can also get a letter from your doctor explaining why the procedure is medically necessary and include medical document(s) that prove medical necessity.
  • What you are requesting: Ask them to reconsider the denial and approve your claim based on the information you provided in the letter.

Click here for a sample appeal letter.

3. Contact your state’s Department of Insurance

If you need help filing an appeal, you can contact your state’s Department of Insurance for help. You can also contact them if you need to file a complaint against your insurance company. Click here to find your state’s Department of Insurance website.

Please contact the Breast Implant Information project for help filing an appeal at info@breastimplantinfo.org.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Sample Appeal Letter

Here is a sample appeal letter written for a woman with severe capsular contracture and a ruptured implant who was denied coverage for her breast implant removal surgery. For help writing your own appeal letter, contact us at info@breastimplantinfo.org. Click here to download.


Breast Implant Removal Office
555 Smiles Way
Healthytown, DC 55555

April 6, 2018

XYZ Claims Department
Attention: Appeals
167 Daisy Lane
Milwaukee, OK 12345

RE: Appeal for Denial of Claim Submitted by Jane Doe

Group/Policy number: 1425-2345-1234
Date(s) of service: February 31, 2018

Dear XYZ Claims Department:

I am writing on behalf of my patient, Jane Doe, to appeal XYZ’s decision to deny coverage for her breast implant removal surgery. I recommended the surgery because Ms. Doe has severe capsular contracture, which is causing her severe pain, restricting her movements, and interfering with mammography. In addition, her right implant is broken.

Your denial letter dated November 3, 2017, states that coverage for this procedure was denied because Ms. Doe’s “current condition does not meet the needed requirements and a bilateral breast revision is not medically necessary.” According to your letter, that determination was based on XYZ’s Coverage Criteria #567 and the details of her case. Your review concluded that because Ms. Doe has “not had breast cancer surgery or a breast injury,” you cannot approve the request for explant surgery.

We respectfully ask you to reconsider that decision. According to page 23 of my patient’s XYZ Medical Policy document (copy enclosed), Ms. Doe’s plan covers all “medically necessary” services that are not expressly excluded. Her plan does exclude cosmetic procedures; however, Ms. Doe’s implant removal is NOT a cosmetic procedure. Although Ms. Doe initially had the implants placed for cosmetic reasons, I recommended permanent removal solely to treat her present medical condition.

A review of XYZ’s Coverage Criteria #567 confirms my view that removal of her implants should be considered medically necessary. The guideline states:

Removal of breast implants for any of the following conditions may be medically necessary:
– Broken or failed implant;
– Infection;
– Implant extrusion;
– Siliconoma or granuloma;
– Interference with breast cancer;
– Breast pain; and
– Painful contraction”

Ms. Doe meets several of the above-stated criteria. I diagnosed her with Baker Grade IV capsular contracture (i.e. “painful contraction”) in her left breast, which is causing her chronic pain, restricting her movements, and interfering with mammography. Because of the pain, Ms. Doe regularly takes pain medication. Additionally, the MRI detected that Ms. Doe’s right silicone gel implant has broken (failed).

Consequently, based on the aforementioned language of the XYZ Medical Policy document and XYZ Coverage Criteria #567, XYZ should consider Ms. Doe’s implant removal a medically necessary procedure. Surgical removal of breast implants is the standard medical treatment for severe capsular contracture. The surgery is not intended to improve her appearance, rather it is intended to relieve her pain and restore her functioning. There is no other equally effective treatment available to Ms. Doe that is more conservative or less costly. Without removal, Ms. Doe will continue to experience severe pain and restricted movement, and her capsular contracture will make future screening mammograms difficult, if not impossible.

Based on this information, I request that you reconsider your denial and approve coverage for Jane Doe’s breast implant removal surgery. For your convenience, I have enclosed copies of all Ms. Doe’s relevant medical records. If you need additional information, please do not hesitate to contact me at (111) 111-1111 or doctor@iworkhere.org.

Thank you for your immediate attention to this matter.

Sincerely,

Dr. David Healthcare, Chief of Breast Implant Removal Operations
NPI# 1234567890

Enclosures:
Ms. Doe’s XYZ Medical Policy
Ms. Doe’s Office Visit Notes from 11/21/2017
MRI Report from 12/10/2017
Ms. Doe’s post-operative report from 2/31/2018


	

Sample Letter of Medical Necessity

Here is a sample letter of medical necessity written for a woman with ruptured silicone gel implants and severe capsular contracture. For help writing your own letter of medical necessity, contact us at info@breastimplantinfo.orgClick here to download.


Breast Implant Removal Office
555 Smiles Way
Healthytown, DC 55555

January 5, 2018

XYZ Claims Department
167 Daisy Lane
Milwaukee, OK 12345

RE: Letter of Medical Necessity for Jane Doe

Group/policy number: 1425-2345-1234
Date(s) of service: January 2, 2018

Dear XYZ Claims Department:

I am writing on behalf of Jane Doe, to document medical necessity and request prior-authorization for explantation of two silicone gel breast implants. Ms. Doe is a 56-year-old female with rupture of her right implant, Baker level III capsular contracture in her left implant, and significant pain in both breasts. She has been in my care since September 21, 2017. Ms. Doe requires an explantation with permanent removal of both implants.

As a result of her pain, Ms. Doe has experienced significant deficits in her daily functioning, including not being able to reach above her head, get dressed, or drive to work. She has previously taken a variety of over-the-counter and prescription pain medications, which have not alleviated her pain. The attached medical records document Ms. Doe’s clinical condition and medical necessity for permanent explantation of both breast implants. There is no equally effective course of treatment available for this patient that is more conservative or less costly.
My patient’s XYZ policy states the following:

“Removal of breast implants that were initially placed for cosmetic purposes is covered when it is considered medically necessary to treat illness or restore the functioning of a body part.”

According to the medical policy of XYZ, Ms. Doe’s breast implant removal should be covered because she has severe capsular contracture that interferes with her daily functioning and has interfered with mammography. Removal of her breast implants and scar tissue surrounding them should relieve her breast pain and eliminate her capsular contracture.

Surgical implant removal is the standard treatment for severe capsular contracture and ruptured silicone-gel breast implants, and this procedure is clinically appropriate for my patient’s condition. Based on the language above, this procedure should be considered medically necessary.

I ask that you take the above information into consideration and offer coverage for Ms. Doe’s medically necessary explant surgery. Should you require additional information, please feel free to contact me at (111) 111-1111 or doctor@iworkhere.org.

Sincerely,

Dr. David Healthcare, Chief of Breast Implant Removal Operations
NPI# 1234567890

Enclosures:
Ms. Doe’s Office Visit Notes from 9/21/2017
MRI Report from 11/10/2017
Ms. Doe’s post-operative report from 1/2/2018

Breast Pain, Redness, or Swelling


You may experience breast pain immediately after your surgery or years after your surgery. It’s important to find out what is causing your breast pain so that you can try to reduce it.

As with any surgery, augmentation patients should expect to feel pain immediately after surgery. However, pain that lasts for months or longer can have many different causes and requires treatment. It can be a sign of an infection, especially if the pain is accompanied by redness, swelling, and tenderness.

Pain can also be caused by capsular contracture, which is when scar tissue that has developed around the implant tightens or hardens. The breast will feel hard and may change shape. The more severe the capsular contracture becomes, the more pain you will experience.

Nerve injury can also cause chronic breast pain or loss of sensation (numbness) of the breast and nipples. Studies have found that between about 13 and 15% of augmentation patients experienced nerve injury or changes in sensation after surgery. Damaged nerves heal slowly and may not ever heal. If the nerve injury is severe enough, additional surgery may be recommended.

Swelling in the breast can be caused by infection, rupture, an inflammation, or Anaplastic Large Cell Lymphoma (ALCL), a cancer of the immune system. If you notice swelling in your breasts, your doctor should test the fluid around your implant for signs of bacteria or signs of cancer.

All articles have been reviewed and approved by Diana Zuckerman, PhD,  and other senior staff.

CMS Payment Rule Seen as Bad for Some Patients

Joyce Frieden, MedPage Today, April 10, 2018

New final regulations on the Affordable Care Act (ACA) health insurance exchanges issued by the Centers for Medicare & Medicaid Services (CMS) have drawn mixed reactions from health policy experts and others.

The rule makes a number of changes to the exchanges, including:

  • Expanding the number of “benchmark” plans from which states can choose to model their coverage of the 10 “essential health benefit” (EHB) categories included in the ACA, potentially allowing states to choose plans with more generous or skimpier coverage than is currently offered on their exchanges.
  • Adding several new “hardship exemptions” to allow consumers to avoid paying a penalty for not buying health insurance. One exemption is for consumers who live in an area in which there are no health plans offered for them on the exchange, or only a single plan offered which is unaffordable. Another exemption is for consumers who live in an area in which the only health plans offered provide coverage of abortions, in cases where that conflicts with the consumer’s personal beliefs.
  • Allowing states to adjust the “medical loss ratio,” which determines what percentage of a health insurer’s revenue must be used for paying healthcare costs. Currently, according to the ACA, health insurers must spend at least 80% of their revenue on healthcare claims and quality improvement, with the rest going toward overhead and profit.
  • Increasing the percentage premium increase which requires review by insurance regulators. Under current ACA rules, review is triggered if an insurer requests to increase rates by an average of 10% or more; the new regulations increase that threshold to 15%.

“The final rule will mitigate the harmful impacts of Obamacare and empower states to regulate their insurance market,” CMS said Monday in a press release on the regulations. “The rule will do this by advancing the Administration’s goals to increase state flexibility, improve affordability, strengthen program integrity, empower consumers, promote stability, and reduce unnecessary regulatory burdens imposed by the Patient Protection and Affordable Care Act.” The release also asserted that the ACA “has led to higher premiums and fewer choices” and that the ACA “has priced many consumers out of the insurance market.”

Premium Increases for Comprehensive Plans

“The plan to allow the sale of policies with skimpier essential health benefits will inevitably cause premiums for good health insurance policies (the kind currently available through the ACA) to increase,” Diana Zuckerman, PhD, president of the National Center for Health Research, an organization that conducts, analyzes, and explains health-related research, wrote in an email.

“If very healthy people can buy skimpy health insurance policies, then people who know that they have health problems will be the only ones buying the better policies — resulting in an increase in costs. In other words, people with pre-existing health conditions such as cancer, heart disease, diabetes, and rare diseases, will be paying much more than anyone else — an outcome that most Americans do not want. The bottom line is that the result of these regulations will be exactly the opposite of the stated goal: rather than making healthcare more affordable, this would make health care much less affordable for the people who need it most.” […]

Read the original article here.

Patient Advocacy Groups Take In Millions From Drugmakers. Is There A Payback?

Emily Kopp, Sydney Lupkin, and Elizabeth Lucas, Kaiser Health News: April 6, 2018

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 — the most recent full year in which documents required by the Internal Revenue Service were available — dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease — such as arthritis, heart disease or various cancers — some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more to individual groups that represent patients who rely on their drugs. The database identifies over 1,200 patient groups. Of those, 594 accepted money from the drugmakers in the database.

The financial ties are troubling if they cause even one patient group to act in a way that’s “not fully representing the interest of its constituents,” said Matthew McCoy, a medical ethics professor at the University of Pennsylvania who co-authored a 2017 study about patient advocacy groups’ influence and transparency.

Notably, such groups have been silent or slow to complain about high or escalating prices, a prime concern of patients.

“When so many patient organizations are being influenced in this way, it can shift our whole approach to health policy, taking away from the interests of patients and towards the interests of industry,” McCoy said. “That’s not just a problem for the patients and caregivers that particular patient organizations serve; that’s a problem for everyone.”

Bristol-Myers Squibb provides a stark example of how patient groups are valued. In 2015, it spent more than $20.5 million on patient groups, compared with $2.9 million on federal lobbying and less than $1 million on major trade associations, according to public records and company disclosures. The company said its decisions regarding lobbying and contributions to patient groups are “unrelated.”

“Bristol-Myers Squibb is focused on supporting a health care environment that rewards innovation and ensures access to medicines for patients,” said spokeswoman Laura Hortas. “The company supports patient organizations with this shared objective.”

The first-of-its-kind database, compiled by Kaiser Health News, tallies the money from Big Pharma to patient groups. KHN examined the 20 pharmaceutical firms included in the S&P 500, 14 of which were transparent — in varying degrees — about giving money to patient groups. Pre$cription for Power is based on information contained in charitable giving reports from company websites and federal 990 regulatory filings.

It spotlights donations pharma companies made to patient groups large and small. The recipients include well-known disease groups, like the American Diabetes Association, with revenues of hundreds of millions of dollars; high-profile foundations like Susan G. Komen, a patient group focused on breast cancer; and smaller, lesser-known groups, like the Caring Ambassadors Program, which focuses on lung cancer and hepatitis C.

The data show that 15 patient groups — with annual revenues as large as $3.6 million — relied on the pharmaceutical companies for at least 20 percent of their revenue, and some relied on them for more than half of their revenue. The database explores only a slice of the pharmaceutical industry’s giving overall and will be expanded with more companies and groups over time.

“It’s clear that more transparency in this space is vitally important,” said Sen. Claire McCaskill (D-Mo.), who has been investigating the links between patient advocates and opioid manufacturers and is considering legislation to track funding. “This database is one step forward in that effort, but we also need Congress to act.”

What Drives The Money Flow

The financial ties between drugmakers and the organizations that represent those who use or prescribe their blockbuster medicines have been of growing concern as drug prices escalate. The Senate investigated conflicts of interest in the run-up to the passage of the 2010 Physician Payments Sunshine Act — a law that required payments to physicians from makers of drugs and devices to be registered on a public website — but patient groups were not addressed in the bill.

Some of the patient groups with ties to trade groups echo industry talking points in media campaigns and letters to federal agencies, and do little else. And patients, supported by pharma, are dispatched to state capitals and Washington to support research funding. Some groups send patients updates on the newest drugs and industry products.

“It’s through groups like this that patients often learn about illnesses and treatments,” said Rick Claypool, a research director for Public Citizen, a consumer advocacy group that says it does not accept pharmaceutical funding.

For the patient group Caring Ambassadors Program, industry funds are needed to make up for a lack of public funding, said the group’s executive director, Lorren Sandt. According to IRS filings and published company reports, in 2015 the group received $413,000, the bulk of which came from one company, AbbVie, which makes a hepatitis C treatment and has been testing a new lung cancer drug, Rova-T, not yet approved. She said the money had no influence on the Caring Ambassadors Program’s priorities.

“There aren’t a lot of large pockets of funding outside of the pharmaceutical money,” Sandt said. “We take it where we can find it.”

Other patient groups such as The National Women’s Health Network, based in Washington, D.C., make sacrifices to avoid pharmaceutical funding. That includes operating with a small staff in a “modest” office building with few windows and outdated computers, according to executive director Cindy Pearson. “You can see the effect of our approach to funding as soon as you walk [in] the door.”

Pearson said it’s hard for patient groups not to be influenced by the funder, even if they proclaim independence. Patient groups “build relationships with their funders and feel in sync and have sympathy” for them. “It’s human nature. It’s not evil or weak, but it’s wrong.” […]

They Weren’t Always Backed By Pharma

Into the ’80s and early ’90s, patient lobbying was generally limited and self-funded with only one or two affluent patients from an organization traveling to Washington on a given day, said Diana Zuckerman, president of the nonprofit National Center for Health Research.

But the power of patient-lobbyists became apparent after a successful campaign by AIDS patients led to government action and a national push to find drugs to treat the then-terminal disease. Zuckerman said she will never forget when two women visited her office and asked how breast cancer patients could be as effective as the AIDS patients.

“At the time, there were no breast cancer patients advocating for money or anything else. It’s hard to believe,” she said. “I still remember that conversation, because it was really a turning point.”

Soon after, breast cancer patients started visiting the Hill more frequently. Patients with other diseases followed. Over time, patients’ voices became a potent force, often with industry support.

Even some wealthy, high-profile organizations take industry money: For example, $459,000 of Susan G. Komen’s $118 million in 2015 revenue came from drugmakers in the database, according to public disclosures. Asked about the pharma money, the foundation said it has institutional processes in place to ensure that “no corporate partner — pharma or otherwise — decides our mission priorities,” including a scientific advisory board — free of sponsor influence — that reviews its research program.

Today, patient advocacy groups flush with more industry dollars fly patients in for testimony and training about how to lobby for their drugs.

Some years ago, as the groups increased in number, Zuckerman said, she started getting email invitations from advocacy groups to attend so-called lobbying days explicitly sponsored by the pharmaceutical industry. The hosts often promised training and usually some kind of keynote speaker at a luncheon in Washington — plus a potential scholarship to cover travel. Now, lobbying days involving dozens of patients from a single group are part of the landscape.

Dan Boston, president of lobbying firm Health Policy Source, said, “It would be naive to think these people on a Tuesday afternoon just happen to turn up in XYZ places,” adding that the money isn’t necessarily a bad thing. Money tends to flow toward citizen groups that already have the same priorities as their funders, he said. […]

Read the original article here.

Interference with Breast Cancer Detection


Breast implants make it more difficult to detect breast cancer. If you are considering getting breast implants or already have breast implants, it is important to know how they can make mammography and breast exams less accurate.

Mammography is used to screen for and detect breast cancer. Breast implants make mammography less accurate because they can hide cancer that is growing behind or around the implant. 1

A mammogram is a type of x-ray. Breast tissue will look grey on the mammogram, and cancer will look white. In a mammogram, implants are also white and will look like a bright white orb. If there is cancer in breast tissue that is below or very near the implant on the mammogram, it probably will not be visible, and therefore won’t be detected.

Here is an example of what implants look like on a mammogram:2

Severe capsular contracture can interfere even more with the accuracy of mammography. It can also cause mammography to be unbearably painful. Capsular contracture is when the scar tissue capsule around the implant tightens and hardens. If you have severe capsular contracture, it may not be possible for you to have a mammogram.

If you have breast implants and need to have a mammogram, you should tell the technician that you have breast implants. You can go to a mammography center that has experience doing mammograms on women with breast implants. The technician will need to take extra x-ray pictures and will have to push your implants to the side, which can be painful.

Mammography also can cause breast implants to break (rupture) or leak. If you have silicone gel-filled implants, this rupture may not be noticeable, but it can cause pain or health problems. To prevent extensive leakage, it is important to have regular breast MRIs to check for silicone gel leakage. If the rupture is not detected, silicone gel can leak through the body and cause serious medical problems.

If you have silicone gel breast implants that are leaking, they can cause lumps (silicone granulomas) that are mistaken for breast cancer. It can also be difficult to know when a lump really is breast cancer. If you have any lumps, be sure to have them checked for cancer right away. If they are from leaking silicone, it is important to have your implants removed.

All articles have been reviewed and approved by Diana Zuckerman, PhD, and other senior staff.